Tag Archives: breakthrough therapies
By Ben Comer | Published: May 7, 2013
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]
By Ben Comer | Published: February 5, 2013
Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.